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Course

Pharma Clinical, Regulatory, and Compliance

BIOL-40381

Learn about Pharma Clinical, Regulatory, and Compliance

This course provides an in-depth understanding of the clinical trial process, regulatory requirements, and compliance issues in the pharmaceutical industry. Students will learn about the phases of clinical trials, including the design, conduct, and analysis of clinical trials, and the ethical considerations in human subjects’ research. Additionally, students will gain an understanding of the regulatory framework for drug development, including the role of the FDA and other regulatory bodies, and the submission and review process for new drug applications. The course will also cover compliance issues, including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP), and the importance of ensuring regulatory compliance throughout the drug development process.

Note: This new course is scheduled to launch in Winter 2025. 


Topics

 
  • Introduction to Clinical Research and Drug Development
  • Good Clinical Practice - Guidelines and Regulations
  • Clinital Trial Operations and Management
  • Informed Consent and Patient Recruitment
  • Pharmacovigilance and Drug Safety
  • Regulatory Submissions and Approvals
  • Compliance in Clinical Trials
  • Quality Assurance in Clinical Research
  • Future Trends in Clinical Research and Compliance

Learning Objectives

 
By the end of this course, students will be able to: 
  • Understand and communicate the importance of SISPQ (Safety, Identity, Strength (Potency), Purity and Quality (Quality Management Systems and Quality by Design)
  • Understand and communicate the importance of well-designed, randomized, placebo controlled, double-blinded clinical trials including the protection of human subjects and current Good Clinical Practice (cGCP)
  • Understand the importance of a label and the background strategies involved in designing a clinical trial with the needed statistical significance

Prerequisites

 
There are no required prerequisites for this course. A bachelor’s degree in the life or physical sciences or more than ten years of biopharmaceutical industry, academic, or clinical experience with a secondary degree will help. 
 

Format

 
This course is offered in an online asynchronous format. There are no set meeting times, however, students follow a weekly schedule and there will be deadlines to meet in terms of course requirements. This course cannot be completed at an accelerated rate.

Course Information

Online
3.00 units
$845.00

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This course applies to these programs

Drug Discovery and Development

Course sessions

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Section ID:

187278

Class type:

Online Asynchronous.

This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.

Textbooks:

No textbook required.

Policies:

  • No refunds after: 1/20/2025

Schedule:

No information available at this time.
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Instructor: Aditya Das

Aditya Das
As the Founder and Principal at Pharmaceutical Consulting LLC, Aditya Das coordinates the interface between client needs and external services/capabilities to facilitate strategic positioning for optimal product development and global registration. Services provided to clients in response to specific requests include regulatory input, risk analysis, cost estimates, process design, and combination (drug/device) product development for both small and macromolecules. Currently he is focused on bringing his own products to market. In addition to a suckable ibuprofen troche, he is developing a portfolio of respirable engineered spray dried dry powder products.He has been involved in combination biopharmaceutical product development for more than 32 years related to parenteral (pulmonary, transdermal, intravenous and implanted) and oral drug delivery therapeutic strategies. Aditya has authored and coordinated the filing of 29 IND's for both small and macromolecules and assisted with the successful submission and registration of 3 NDA’s (for Dry Powder Inhaled Insulin, "Exubera®", approved by the FDA and EMA in Jan 2006; Thermal Aerosol Vapor Generated Staccato Loxapine, “Adasuve®” approved by the FDA and EMA Dec 2012 and Dry Powder Inhaled Tobramycin, “Tobi Podhaler®” approved by the FDA and EMA March 2013). These efforts were directed to combination products used for the treatment of infectious, allergic, genetic and neurological diseases. He is an Inventor on 9 issued Patents covering thiocationic lipids for gene delivery, a taste masked Ibuprofen suckable tablet and spray dried formulations for nasal and inhaled drug delivery and 17 peer reviewed publications.

Aditya earned his Ph.D. degree in Chemical Engineering studying the effects of inhaled inorganic dusts and their role in the etiology of silicosis at a joint program between West Virginia University and the National Institutes for Occupational Safety and Health and an MBA (Strategy) from the University of California at Irvine. He also earned an MS degree in Chemical Engineering from Carnegie Mellon University supported by a Mellon Fellowship and a BS degree in Chemical Engineering from the University of New Hampshire supported by Scholarships from the International Students Office and a Fellowship from the Winchester R. Wood Memorial Foundation.
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